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NCT03926767
Additional Effect of Pain Neuroscience Education to Orofacial and Neck Exercises in Temporomandibular Disorders
NA trial testing Pain Neuroscience Education (PNE) in Temporomandibular Disorders in 148 participants. Completed in 28 February 2022.
30 October 2020
Quick facts
| Lead sponsor | University of Sao Paulo |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 148 |
| Start date | 10 May 2019 |
| Primary completion | 30 October 2020 |
| Estimated completion | 28 February 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Pain Neuroscience Education (PNE)
- Orofacial Manual Therapy
- Orofacial Exercises
- Neck Motor Control Exercises
Conditions studied
- Temporomandibular Disorders — all drugs for Temporomandibular Disorders →
Sponsor
University of Sao Paulo
Who can join
Adults 18 to 55, any sex, with Temporomandibular Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study will be to verify the additional effect of Pain Neuroscience Education program to orofacial manual therapy and orofacial and neck motor control exercises for pain intensity and disability and for the secondary outcomes pain self-efficacy, kinesiophobia, and overall perception of improvement in patients with Temporomandibular Disorders (TMD). This study will be a randomized clinical trial comprising a sample of 148 participants. Subjects will undergo a screening process to verify those presenting a diagnosis of painful TMD confirmed by the Research Diagnostic Criteria (RDC/TMD), between 18 and 55 years of both genders, and then the volunteers will be randomized into two groups (G1: Pain Neuroscience Education + Orofacial Manual Therapy/orofacial exercises/neck motor control exercises vs. G2: Orofacial Manual Therapy/orofacial exercises/neck motor control exercises). These volunteers will be recruited at the Dentistry Clinic of the University of São Paulo's School of Dentistry of Ribeirão Preto - University of São Paulo. The intervention will be administered twice a week for 6 weeks by a single therapist lasting 1 hour per session. The primary outcome will be pain intensity and disability and the secondary outcomes will be pain self-efficacy, kinesiophobia and overall perception of improvement. The participants will be assessed immediate after the last session and at one and three-month follow-ups.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Education-Enhanced Conventional Care versus Conventional Care Alone for Temporomandibular Disorders: A Randomized Controlled Trial.
Aguiar ADS, Moseley GL, Bataglion C, Azevedo B, et al · · 2023 · cited 16× · PMID 36220481 · DOI 10.1016/j.jpain.2022.09.012 -
Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial.
Dos Santos Aguiar A, Bataglion C, Felício LR, Azevedo B, et al · · 2021 · cited 5× · PMID 34488856 · DOI 10.1186/s13063-021-05532-x
Verify or expand the search:
- PubMed search for NCT03926767
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03926767 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo
- Last refreshed: 1 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03926767.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing